Our Services

At Mediscient Devices, we offer innovative medical injectors and a range of services that includes benchmarking, product design, process development, assembly machines, and production. Our team of experts is dedicated to providing you with a seamless experience and ensuring the success of your medical equipment manufacturing projects.

Benchmarking

Design

Prototyping

Process Design

Mold Development

Assembly Machine Development

Product Development

Production Line
Development

Technical Documentation
& Product Filing

Commercial
Supply

Product & Process Validations

Product Development

User step analysis
Force testing at each and every step
- 21CFR compliant testing equipment
- With audit trail reporting
Material Identification tests in associated labs
- FTIR
- DSC
- Residue
Patent Study
- Inhouse study
- Patent attorney associate
Mechanism study:
- Measuring every dimension of all component parts
- Measuring forces of every functional feature of all component parts
- Identifying part manufacturability details like parting lines, gate points, ejection points, etc.
- Hot tip cutters, surgical cutters, handheld motorized micro cutter for opening up the devices/ cutting sections
- Reverse Engineering with NABL calibrated equipment
  - 1micron LC camera Vision Measurement Machine (VMM)
  - 21 CFR Universal Testing Machine (UTM)
  - Different Force gauges
  - Vernier calipers, Micrometers, height gauge, surface plate, runout dial gauge and stylus, etc.
  - Custom gauges
- 3d model generation
  - Part modeling
  - Generating parting lines
  - Creating gate points and ejection points
  - Component assembly
  - Rendering

Review user step, Refer URS, all other requirements and prepare Design Inputs
Conceptualize design modification required
Patent Study, modify concept if required per IP search
Engineering data generation for finalized design
Analyse assembly for designed Process
Selection of Materials for the performance and compliances required
Define fits and value of interference based on material property, force dynamics and other required analysis
DFM, DFA (DQ) Analysis and design correction where required
Generate BOM
Tolerance analysis, Detailed Engineering drawings
Define dimensions critical to Function & processing (CTQs)
DFMEA, Maintain DHF, DV
Proto Part, Proto bought outs etc.
Assembly analysis and Design modification for improvement if needed
Prepare DHF (Design brief, Design Input, Design Output, Design Verification, DFMEA)
Product Testing/Certification
- Control Plan from AFMEA, DFMEA and PFMEA
- Primary functions of the device
- Applicable ISO standards
- USP class VI, biocompatibility, DMF requirements for USFDA/EUMDR
- Shelf life/Accelerated aging test

Production Line Development

Define process requirements
Assembly sequencing
Define assembly requirements
Define, Assembly Concept
Define SPM/equipment for assembly
Molding process design and development
Validation protocols development (IQ, OQ, PQ)
Define tool certification/validation requirements and ensuring all relevant data.
Define Scientific Mold Validation Protocol
Define product approval criteria, batch release criteria
Define product testing protocols (3rd party lab)
Listing Product certification requirements

Define, Assembly Concept and relevant equipment.
Selection of SPM/automation machine supplier
Define SPM/equipment for pre-assembly
Develop SPM/equipment for pre-assembly (optional, not is scope)
Assembly line set up support
Validate SPM/assembly equipment
Define testing concept (for testing equipment, testing method)
Define testing equipment
Validate testing equipment, test methods
Define calibration period for testing equipment (if required)

Mold development
- Creating tool specification all plastics parts, Bought outs
- Review and modify tool design and tool manufacturing process
- Mould building monitoring, Tool trials with basic SIM process
- Review, analyse, and plan action on trial results
- Tool corrections, trials and sample review
- Tool feature alterations to achieve design target
- Generate database for SIM in Production tool.
- Process validation and Record
Mold Qualification
- Follow SIM established during preliminary qualification and manufacture required quantity for third party testing like 11608 etc.
- Documentation of sample build and review of test results
Process Validation
- Mold Installation, Process Validation
- Follow SIM established during preliminary qualification. Monitor & approve manufactured parts, required for third party testing
- Installation qualification (IQ), Operation qualification (OQ)
- Evaluate production, monitor and control Assembly and testing, Documentation of sample build

Product Filing & Commercial Supply

Design History File (DHF)
- User Needs (URS)
- Design Input
- Design Output
- Design Verification
- Bench testing
- Design Validation
- DV & DVL testing
Risk Management File
- Risk Management Plan (RMP)
- Hazard Assessment (IHA)
- Different types of Failure Mode Analysis
- Benefit Risk
- Risk Summary
US DMF filing
Device History File

Verify process requirements
Verify requirements (Man, Machine, Method)
Verify Manufacturing process design and development
Validation protocols development (IQ,OQ,PQ)
Verify tool certification requirements and ensuring all relevant data.
Verify Scientific Mold Validation Protocols
Verify product approval criterias
Verify product testing protocols (for inhouse tests)
Verify Assembly sequencing and risk assessments

Our Services

Product Development

Production Line Development

Technical Documentation & Product Filing

Commercial Supply

Product & Process Validations

Product Development

Production Line Development

Product Filing & Commercial Supply

Production Line
Development

Technical Documentation
& Product Filing

Commercial
Supply